EQ-5D VAS Score Research Articles

Factors and Predictors of Health Related Quality of Life of the General Population of Pakistan.

Background and ObjectiveThe standards of living, improvement in public health, and medical care in Pakistan are increasing day by day, health-related quality of life (HRQoL) has been increasingly acknowledged in various patient's reported outcomes in Pakistan. However, a large-scale general population-based study on assessing HQRoL in Pakistan was not conducted. Therefore, this study aimed to evaluate HRQoL for the general Pakistani population.Material and MethodsA cross-sectional study with a population sample (n = 16,672) was selected from all Pakistan provinces using a stratified sampling approach. The EQ-5D-3L tool was used to measure the HRQoL of the general population of Pakistan. The descriptive and inferential statistics have been done by using SPSS version 20.ResultsOverall, 121 health states were reported in this study. EQ-5D index and EQ-VAS scores were 0.74 ± 0.32 and 0.75 ± 0.25, respectively. The percentage of people responding to any problems increased with age. Males have better health as compared to females in all age groups. All demographics were significantly associated (P < 0.01) with the mean EQ5D index and VAS scores except residence (p > 0.05). The regression model reported that age was the best predictor of the EQ-5D index scores after adjusting for the covariates (beta = 0.19; p < 0.001). This study provides Pakistani population HRQoL data measured by the EQ-5D tool, based on a national representative sample.ConclusionThe current study concluded that Age, City, Gender, Education, Occupation, Residence, and House occupancy are significantly affecting HRQOL. The socioeconomically deprived groups and females have inferior health status than more advantaged. The trends detected in high-income nations were usually similar to Pakistan.

Patient-Reported Outcomes from the Phase 3 Randomized, Double-Blind, KEYNOTE-826 Trial of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (023)

Patient-Reported Outcomes from the Phase 3 Randomized, Double-Blind, KEYNOTE-826 Trial of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (023)

Home-based Vestibular Rehabilitation: A Feasible and Effective Therapy for Persistent Postural Perceptual Dizziness (A Pilot Study).

Persistent postural-perceptual dizziness (PPPD) is a chronic functional vestibular disorder where there is persistent dizziness or unsteadiness occurring on most days for more than 3 months duration. Treatment recommendations for PPPD include vestibular rehabilitation therapy (VRT) with or without medications and/or cognitive behavioral therapy. This paper is a pilot study designed to compare the effects of Bal Ex as a home-based VRT on the quality of life (EQ-5D), dizziness handicap (DHI) and mental health (DASS-21) against hospital-based VRT. This was an assessor-blinded, randomized controlled pilot study where PPPD patients were randomly selected to undergo Bal Ex, the home-based VRT (intervention group) or hospital-based (control group) VRT. The participants were reviewed at 4 weeks and 12 weeks after the start of therapy to assess the primary endpoints using the subjective improvement in symptoms as reported by patients, changes in DHI scores, DASS-21 scores and EQ5D VAS scores. Thirty PPPD patients successfully completed the study with 15 in each study group. Within 4 weeks, there were significant improvements in the total DHI scores as well as anxiety levels. By the end of 12 weeks, there were significant improvements in the DHI, DASS-21 and EQ5D. The degree of improvement between Bal Ex and the control was comparable. VRT is an effective modality in significantly improving quality of life, dizziness handicap, depression, and anxiety levels within 3 months in PPPD. Preliminary results show Bal Ex is as effective as hospital-based VRT and should be considered as a treatment option for PPPD.

Poor Knee-specific and Generic Patient-reported Outcome Measure Scores at 6 Months Are Associated With Early Revision Knee Arthroplasty: A Study From the Australian Orthopaedic Association National Joint Replacement Registry.

The ability to identify which patients are at a greater risk of early revision knee arthroplasty has important practical and resource implications. Many international arthroplasty registries administer patient-reported outcome measures (PROMs) to provide a holistic assessment of pain, function, and quality of life. However, few PROM scores have been evaluated as potential indicators of early revision knee arthroplasty, and earlier studies have largely focused on knee-specific measures. This national registry-based study asked: (1) Which 6-month postoperative knee-specific and generic PROM scores are associated with early revision knee arthroplasty (defined as revision surgery performed 6 to 24 months after the primary procedure)? (2) Is a clinically important improvement in PROM scores (based on thresholds for the minimal important change) after primary knee arthroplasty associated with a lower risk of early revision? Preoperative and 6-month postoperative PROM scores for patients undergoing primary knee arthroplasty were sourced from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and Arthroplasty Clinical Outcomes Registry National. Between January 2013 and December 2020, PROM data were available for 19,402 primary total knee arthroplasties; these data were linked to AOANJRR data on revision knee arthroplasty. Of these, 3448 procedures were excluded because they did not have 6-month PROM data, they had not reached the 6-month postoperative point, they had died before 24 months, or they had received revision knee arthroplasty before the 6-month PROMs assessment. After these exclusions, data were analyzed for 15,954 primary knee arthroplasties. Associations between knee-specific (knee pain, Oxford Knee Score, and 12-item Knee injury and Osteoarthritis Outcome Score [KOOS-12]) or generic PROM scores (5-level EuroQol quality of life instrument [EQ-5D], EQ VAS, perceived change, and satisfaction) and revision surgery were explored using t-tests, chi-square tests, and regression models. Ninety-four revision procedures were performed at 6 to 24 months, most commonly for infection (39% [37 procedures]). The early revision group was younger than the unrevised group (mean age 64 years versus 68 years) and a between-group difference in American Society of Anesthesiologists (ASA) grade was noted. Apart from a small difference in preoperative low back pain for the early revision group (mean low back pain VAS 4.2 points for the early revision group versus 3.3 points for the unrevised group), there were no between-group differences in preoperative knee-specific or generic PROM scores on univariate analysis. As the inclusion of ASA grade or low back pain score did not alter the model results, the final multivariable model included only the most clinically plausible confounders (age and gender) as covariates. Multivariable models (adjusting for age and gender) were also used to examine the association between a clinically important improvement in PROM scores (based on published thresholds for minimal important change) and the likelihood of early revision. After adjusting for age and gender, poor postoperative knee pain, Oxford, KOOS-12, EQ-5D, and EQ VAS scores were all associated with early revision. A one-unit increase (worsening) in knee pain at 6 months was associated with a 31% increase in the likelihood of revision (RR 1.31 [95% confidence interval (CI) 1.19 to 1.43]; p < 0.001). Reflecting the reversed scoring direction, a one-unit increase (improvement) in Oxford or KOOS-12 score was associated with a 9% and 5% reduction in revision risk, respectively (RR for Oxford: 0.91 [95% CI 0.90 to 0.93]; p < 0.001; RR for KOOS-12 summary: 0.95 [95% CI 0.94 to 0.97]; p < 0.001). Patient dissatisfaction (RR 6.8 [95% CI 3.7 to 12.3]) and patient-perceived worsening (RR 11.7 [95% CI 7.4 to 18.5]) at 6 months were also associated with an increased likelihood of early revision. After adjusting for age and gender, patients who did not achieve a clinically important improvement in PROM scores had a higher risk of early revision (RR 2.9 for the knee pain VAS, RR 4.2 for the Oxford Knee Score, RR 6.3 to 8.6 for KOOS-12, and RR 2.3 for EQ-5D) compared with those who did (reference group). Knee-specific and generic PROM scores offer an efficient approach to identifying patients at greater risk of early revision surgery, using either the 6-month score or the magnitude of improvement. These data indicate that surgeons can use single- and multi-item measures to detect a patient-perceived unsuccessful surgical outcome at 6 months after primary knee arthroplasty. Surgeons should be alert to poor PROM scores at 6 months or small improvements in scores (for example, less than 2 points for knee pain VAS or less than 10.5 points for Oxford Knee Score), which signal a need for direct patient follow-up or expedited clinical review. Level III, therapeutic study.

Health-related quality of life (HRQoL) impact of pembrolizumab (pembro) plus best supportive care (BSC) versus placebo (PBO) plus BSC as second-line (2L) therapy in patients (pts) in Asia with advanced hepatocellular carcinoma (HCC): Phase 3 KEYNOTE-394 study.

4088 Background: In the randomized, double-blind, phase 3 KEYNOTE-394 trial (NCT03062358), pembro + BSC vs PBO + BSC as 2L therapy significantly reduced the risk of death by 21% (HR 0.79, 95% CI 0.63-0.99, P= 0.0180), prolonged PFS (HR 0.74, 95% CI 0.60-0.92, P= 0.0032), and improved ORR (estimated difference 11.4%, 95% CI 6.7-16.0, P= 0.00004) with a manageable safety profile in pts in Asia with advanced HCC and progression on or intolerance to sorafenib or oxaliplatin-based chemotherapy. Here we present the results of prespecified exploratory HRQoL analyses. Methods: EORTC QLQ-C30 and EuroQol-5D3L (EQ5D-3L) questionnaires were administered at baseline (BL); wks 3, 6, 9, 12, 18; every 9 wks thereafter up to 1 yr or end of treatment; at treatment discontinuation, and at the 30-day safety follow-up visit. Pts who received ≥1 dose of study treatment and completed ≥1 HRQoL assessment were included in the analyses. Least squares mean (LSM) score changes from BL to wk 12 were compared using a constrained longitudinal data analysis model, including treatment by study visit interaction and stratification factors as covariates. Kaplan-Meier method was used to estimate time to deterioration (TTD) (time to 1st onset of ≥10-point decline from BL/confirmed by a 2nd adjacent ≥10-point decline from BL) for EORTC QLQ-C30 global health status (GHS)/QoL. Stratified Cox proportional hazards model was used to assess the magnitude of the treatment difference (HR) between treatment arms in TTD with nominal, one-sided P value calculated. Results: The HRQoL population included 450 pts (298 pembro; 152 PBO). HRQoL compliance rate at wk 12 was 95.7% for pembro for both questionnaires and 94.4% for EORTC QLQ-C30 and 95.3% for EQ5D-3L for PBO. There was a statistically significant difference in LSM for change from BL to wk 12, between the two arms for the QLQ-C30 GHS/QoL score and EQ-5D VAS score, with more decline observed in the PBO arm. Difference in LSM for QLQ-C30 GHS/QoL score between pembro (-3.97; 95% CI, -6.38, -1.56) and PBO (-8.40; 95% CI, -11.71, -5.10) arms was 4.43 (95% CI, 0.47, 8.40; P= 0.0142). Difference in LSM for EQ-5D VAS score between pembro (-2.74; 95% CI, -4.51, -0.96) and PBO (-6.94; 95% CI, -9.40, -4.48) arms was 4.20 (95% CI, 1.21, 7.19; P= 0.0030). GHS/QOL mean scores generally remained stable over time in pembro arm. TTD in EORTC QLQ-C30 GHS/QoL score was similar between arms (HR, 0.85; 95% CI, 0.58, 1.25; P= 0.1993). Conclusions: Over 12 wks, pts treated with PBO + BSC showed more decline in HRQoL than those receiving pembro + BSC. Combined with the efficacy and safety results from KEYNOTE-394, as well as other global 2L trials with pembro, including KEYNOTE-240 and KEYNOTE-224, our data support the benefit of pembro as 2L therapy for pts with advanced HCC. Clinical trial information: NCT03062358.

Hemiarthroplasty in complex proximal humeral fractures: preserving unity of the tuberosities with the cap technique improves clinical outcome.

Objectives:The outcome of primary hemiarthroplasty for complex proximal humeral fractures is highly dependent on the position and survival of the tuberosities. Preserving the cuff–tuberosity complex as a unit (named cap technique) is thought to improve the reduction and stability of the tuberosities. We present the first report of the cap technique and compare it with the common intertubercular split technique.Design:Comparative retrospective study on consecutive patientsSetting:Urban level 1 trauma center.Patients/Participants:Included were all patients treated between May 2010 and August 2019 with the Affinis Fracture (Mathys, Switzerland) hemiarthroplasty for complex shoulder fractures. The cap technique was used from February 2015 onward. Minimum follow-up of 11 months. Dementia was an exclusion criterium.Outcome Measure:Clinical evaluation by (normalized) Constant-Murley score, DASH score, and EQ5D-VAS score. Radiological outcomes according to the criteria of Boileau.Results:The cap-technique group consisted of 26 patients. One patient had revision surgery; 23 patients could be evaluated at a mean follow-up of 28 months. The control group consisted of 26 patients. Three patients had revision surgery. Ten patients could be scored at a mean follow-up of 101 months. A statistically significant difference in Constant-Murley score (P = .0121) could be observed between case and control group. There were no significant differences between radiological scores and between revision rates.Conclusion:The cap technique significantly improves clinical outcome in comparison with the intertubercular split technique. However, there was no significant difference in radiographic appearance of the tuberosities.

Association of post-stroke-depression and health-related quality of life three months after the stroke event. Results from the Stroke Cohort Augsburg (SCHANA) study

ABSTRACT Approximately one-third of patients with stroke show depressive symptoms. The so-called post-stroke depression (PSD) has a negative influence on mortality as well as physical and mental conditions. The aim of this study was to analyse the association between PSD and health-related quality of life (HRQOL) in patients with stroke. The analysis was based on data of 326 patients from the Stroke Cohort Augsburg (SCHANA Study) collected after the stroke event by interview and three months later using a postal survey. Depressive symptoms were measured with the Patient-Health Questionnaire (PHQ-9), subjective health status with the EuroQol 5D visual analogue scale (EQ-5D VAS), and HRQOL with the Stroke Impact Scale (SIS). Patients with depressive symptoms were compared to those without depressive symptoms in terms of sociodemographic characteristics and scores of the SIS and the EQ-5D VAS. Multiple linear regression models were calculated to investigate the association between PSD and subjective health status and HRQOL. Three months after the stroke, 17.8% of patients had depressive symptoms. Patients with PSD showed significantly worse SIS and EQ-5D VAS scores. In addition, an independent negative linear association between PSD and subjective health status and between PSD and all domains of SIS could be found. The study confirmed that PSD is common in patients with mild stroke and negatively related to all stroke-specific HRQOL domains. The results underline the importance of early screening for PSD in stroke patients since it may hinder a successful rehabilitation.

Short leg cast versus orthotic removable support for the management of pseudo-Jones avulsion fracture: A systematic review and meta-analysis

BackgroundThe fifth metatarsal base avulsion fracture (i.e., Pseudo-Jones fracture) is one of the most common foot fractures. The management of pseudo-Jones fractures could be carried out surgically or conservatively. This systematic review and meta-analysis aimed to provide an update about the efficacy of orthotic removable support compared to short-leg casting for individuals with pseudo-Jones fracture. MethodsWe searched Embase, Medline, and Cochrane Central register of Controlled Trials (CENTRAL) for randomized controlled trials (RCTs) that compared the clinical outcomes of orthotic removable support and short-leg cast for adult individuals with a fifth metatarsal base avulsion fracture. We used 95% as a confidence level and P <0.05 as a threshold. The standardized mean difference (SMD) was used for the continuous outcomes, and the risk ratio (RR) was used for the dichotomous outcomes. ResultsA total of 6 RCTs incorporating 403 individuals out were deemed eligible. There was no significant difference between orthotic removable support and short-leg casting regarding AOFAS score (standardized mean difference (SMD)= 0.31, 95% CI -0.17 to 0.8), pain on VAS score (SMD= -0.08, 95% CI -0.39 to 0.22), VAS-FA score (SMD= 0.22, 95% CI -0.19 to 0.62) EQ-5D VAS score, and non-union rate (RR=0.37, 95% CI 0.05 to 2.74). ConclusionThe current meta-analysis reveals that there is no difference between orthotic removable support and short-leg casting for the conservative management of individuals sustaining pseudo-Jones fracture.

Patient-reported chronic rhinosinusitis disease control is a valid measure of disease burden.

Disease control is an important treatment goal for chronic uncurable conditions such as chronic rhinosinusitis (CRS). The objective of this study was to determine whether patient-reported CRS disease control is a valid reflection of disease burden. Prospective longitudinal study of 300 CRS patients (35% CRS with nasal polyps, 65% CRS without nasal polyps). At enrollment and at a subsequent follow-up timepoint, all participants were asked to rate their CRS disease control as 'not at all', 'a little', 'somewhat', 'very', 'completely' as well as to complete a 22-item Sinonasal Outcome Test (SNOT-22) and the 5-dimension EuroQol general health questionnaire from which the visual analogue scale (EQ-5D VAS) was used. At enrollment and follow-up timepoints, patient-reported CRS disease control was significantly correlated with SNOT-22 and EQ-5D VAS scores. The change in patient-reported CRS disease control was significantly correlated with change in SNOT-22 and change in EQ-5D VAS scores. There was significant cross-sectional and longitudinal correlation between patient-reported control and all SNOT-22 subdomain scores. A SNOT-22 score of ≤25 points or lower, or an EQ-5D VAS score of ≥77 was predictive of having well - (i.e. 'very' or 'completely') controlled CRS. Patient-reported CRS disease control is a valid measure of CRS disease burden and general QOL. A patient-reported assessment of CRS disease control could be considered as a component of a more comprehensive measure of CRS disease control.

The quality of life in women with cervical cancer and precancerous lesions of Han and ethnic minorities in Southwest China

BackgroundAs patients with cervical cancer and precancerous lesions can be diagnosed at early stage and live longer, it is imperative to understand their health-related quality of life so that better cancer-related policies could be promoted and reasonable distribution of limited resources could be implemented. We conducted a cross-sectional study in the Third Affiliated Hospital of Kunming Medical University to assess the health-related quality of life in our targeted population. Due to the characteristics of Yunnan nationality, our study population includes both Han people and ethnic minorities.MethodsA cross-sectional study was conducted from January 2019 to December 2020, and 300 patients were selected, who were initially diagnosed with cervical cancer and cervical intraepithelial neoplasia (CIN) pathologically. EQ-5D questionnaire was used to evaluate their quality of life.ResultsPatients in Han and ethnic minorities showed good comparability. EQ-5D VAS score was statistically significant between Han and ethnic minorities (mean, 85.42 vs. 81.01; P<0.05). EQ-5D utility score was slightly different but without statistical significance between the two groups (mean, 0.959 vs. 0.932; P>0.05). Nationality, economic trouble, menopause status and participation of China National Cervical Cancer Screening Program (CNCCSP) are influencing factors of HRQoL among women with cervical cancer and precancerous lesions. Besides, we also found low awareness in the CNCCSP and human papilloma virus vaccine, as well as low participation in the national screening program.ConclusionThe results of our study imply that the difference of HRQoL does exist between Han people and ethnic minorities with cervical cancer and precancerous lesions. Health providers and health-related departments need to invest more health and financial resources to expand the awareness and participation of the screening project. More efforts should be made in underdeveloped minority areas to assure the accessibility of health resources and interventions. To mitigate economic trouble caused by the diseases, more equal insurance reimbursement should be suggested and implemented in people with or without employee insurance.

No Difference in Functional, Radiographic, and Survivorship Outcomes Between Direct Anterior or Posterior Approach THA: 5-Year Results of a Randomized Trial.

Both the direct anterior approach (DAA) and posterior approach (PA) to THA have known advantages and disadvantages. The comparison between DAA and PA THA has been widely explored during the early postoperative period. However, few randomized trials have compared these approaches at a minimum follow-up of 5 years; doing so would be important to establish any differences in mid-term outcomes or complications. We performed a randomized trial comparing DAA and PA in THA in terms of (1) patient-reported outcome scores, (2) quality of life and functional outcomes assessed by the EQ-5D and 10-meter walk test results, (3) radiographic analysis, and (4) survivorship and surgical complications at a minimum of 5 years follow-up. Two hip specialist surgeons performed both DAA and PA THA using the same THA components at two hospital sites. One hundred twelve patients on the elective THA surgical waitlist were invited to participate in the study. Thirty-four patients did not meet the study's inclusion criteria and were excluded, and three patients declined to participate in the study. The remaining 75 patients who were eligible were randomized into DAA and PA groups. Thirty-seven patients were initially randomized to receive DAA THA, but two did not and were excluded, resulting in 48% (35 of 73) of patients who received DAA THA; 52% (38 of 73) of patients were randomized into and received PA THA. Over a minimum 5 years of follow-up, 3% (1 of 35) of DAA patients were lost to follow-up, and none of the patients undergoing PA THA were lost. A per-protocol analysis was adopted, resulting in further patients being excluded from analysis. Of the 73 study patients, 99% (72; DAA: 35, PA: 37) were analyzed at 1 year, 95% (69; DAA: 34, PA: 35) were analyzed at 2 years, and 72% (52; DAA: 23, PA: 29) were analyzed at 5 years. The primary outcome was the Oxford Hip Score (OHS) and WOMAC score. Secondary outcomes included the EQ-5D and EQ-5D VAS scores, 10-meter walk test results, radiographic evidence of loosening (femoral: lucency > 2 mm at the implant-bone interface, subsidence > 2 mm; acetabular: migration or change in inclination), 5-year survivorship analysis from all-cause revisions, and surgical complications. The study was powered to detect a 10-point difference in the WOMAC score, which is equivalent to the minimum clinically important difference (MCID). There were no differences in primary outcomes (OHS and WOMAC scores) or secondary outcomes (EQ-5D scores, EQ-5D VAS scores, and 10-meter walk test result) between the DAA and PA groups at the 5-year follow-up interval. The median (range) OHS at 5 years was 46 (16 to 48) for DAA and 47 (18 to 48) for PA groups (p = 0.93), and the median WOMAC score was 6 (0 to 81) for DAA and 7 (0 to 59) for PA groups (p = 0.96). The median EQ-5D score was 1 (0.1 to 1) for DAA and 1 (0.5 to 1) for PA groups (p = 0.45), and the median EQ-5D VAS score was 85 (60 to 100) for DAA and 95 (70 to 100) for PA groups (p = 0.29). There were no cases of component loosening on radiographs. There was no difference in component survival between the two approaches at 5 years (DAA: 97% [95% CI 85% to 100%] versus PA: 97% [95% CI 87% to 100%]). Eight of 23 patients in the DAA group reported decreased sensation in the lateral femoral cutaneous nerve distribution. DAA and PA are both effective approaches in performing primary THA. Each approach has its associated risks and complications. The choice of THA should be based on individual patient factors, surgeon experience, and shared decision-making. Early registry data indicate DAA and PA THA are comparable, but longer-term data with larger numbers of patients will be required before one can safely conclude equal survivorship between both approaches. Level I, therapeutic study.

Epidemiology of Neck Pain and Its Impact on Quality-of-Life-A Population-Based, Cross Sectional Study in Singapore.

Cross-sectional, epidemiological study. This study aims to describe the prevalence, risk factors, disability, and quality of life (QoL) burden of neck pain. Neck pain is an increasingly common symptom that results in significant disability and loss of QoL to the individual, and imposes a considerable economic burden to developed countries. A cross-sectional, questionnaire-based study was conducted via multistage random sampling of public households in Singapore on individuals aged 21 and older. Questionnaires were administered face-to-face by trained interviewers. Data analyzed included the prevalence and characteristics of neck pain, its relationship with sociodemographic factors, and its association on QoL and disability via validated questionnaires: EQ5D questionnaire and Neck Disability Index (NDI), respectively. A total of 626 individuals with a median age of 52.0 years (interquartile range 37.0-67.0), and even sex distribution of males (54.0%) and females (46.0%) were included in this study. A total of 144 individuals reported neck pain over the past 6 months, giving a 6-month period prevalence of 23.0%. Among them, nine (6.3%) had chronic, whereas 12 (8.3%) had severe neck pain. Female sex was the only significant risk factor for neck pain on multivariate analysis, with a risk ratio of 1.34 (95% confidence interval [CI] 1.00-1.80, P = 0.049). Individuals with neck pain had mean raw NDI scores of 4.91 ± 6.25, with higher disability seen with increasing pain duration and intensity (P < 0.001 and P = 0.002 respectively). Compared to individuals without neck pain, those with neck pain had poorer QoL with lower EQ5D-Index scores (0.84 ± 0.25 vs. 0.93 ± 0.15; 95% CI 0.046-0.132, P < 0.001) and EQ5D-VAS scores (68.76 ± 14.59 vs. 73.86 ± 13.64; 95% CI 2.510-7.697, P < 0.001). Our findings show that neck pain is a prevalent condition with chronicity and severity of symptoms associated with reduced QoL and increased disability. Population sample health scores can serve as potential reference targets in disease management and aid national health care policy-making.Level of Evidence: 3.

PRO65 Engaging Patients in Drug Development for Regulatory and HTA Decisions: A Case Study in Patients with Hidradenitis Suppurativa

Regulatory agencies and Health Technology Assessment (HTA) bodies are increasingly recognizing the importance of the patient’s voice in new drug development and reimbursement decisions. However, inconsistencies remain on the best practices to describe patients’ perspectives living with disease. This case study provides an example of a systematic qualitative study in Hidradenitis Suppurativa (HS) to demonstrate impact of disease, unmet need, and important aspects of treatment to patients with HS. This information is critical to assess patient benefit for informed regulatory and reimbursement decisions. A total of 36 qualitative interviews were conducted in patients with moderate to severe HS. Patients were asked open-ended questions regarding living with HS including specific symptoms of HS, impact of HS on their functioning, well-being, daily activities, and other specific treatment outcomes meaningful to patients. Impact on health-related quality of life (HRQOL) was assessed by the Dermatology Life Quality Index (DLQI) and 5-level EuroQoL-5D (EQ-5D-5L). In general, subjects reported living with HS as painful, difficult, and embarrassing. Commonly reported (>60%) symptoms of HS included: pain, drainage, itching, swelling, odor, tenderness, heat, and lesion-related pressure. Pain was reported as the most bothersome and difficult to manage symptom. Individuals with HS also reported being negatively impacted in terms of social/emotional functioning, and ability to perform daily activities with a DLQI mean total score of 14 ± 7, indicating a large effect on a patient’s life. General health status was significantly impaired with mean EQ-5D VAS score of 67 ± 18. As an effective treatment, patients indicated ≥10% improvement in pain as meaningful. Insights gathered from patients with HS help describe the patients’ experience. Developing a validated PRO instrument to evaluate HS symptoms and impact on HRQOL will be critical to demonstrate patient benefit with a novel therapy and help inform regulatory and HTA decisions.

Quality of life recovery after laparoscopic high uterosacral ligament suspension: a single centre observational study

ObjectiveLaparoscopic high uterosacral ligament suspension (l-HUSLS) is a laparoscopic-transposed vaginal technique for the treatment of pelvic organ prolapse. Nowadays data regarding quality of life and sexual functions in patients who underwent l-HUSLS for pelvic organ prolapse are few and generic with most of the study investigating the anatomical outcome. For these reasons, the aim of our study is to evaluate these subjective outcomes in women undergoing this surgical procedure with the support of validated questionnaires. Study designThis is a retrospective study with the primary aim of analysing the quality of life, sexual function, patient satisfaction rates and anatomical outcome among patients who underwent l-HUSLS in our institution. The SPSS Version 26.0 for Windows (Statistical package for the social studies, Chicago, IL, USA) was used for the statistical analysis. ResultsA total of 60 patients underwent l-HUSLS between 2016 and 2018. All patients had a high grade of apical prolapse. No intraoperative and major postoperative complications were registered. The median follow-up was 24 months (24−48). PGI-I score was 1–2 in 55 (91.6 %) women. We observed a significant improvement of EQ-5D index and VAS scores from the baseline to the 2 years follow-up: from 0.72 (0.67−1) to 0.91 (0.79−1) and from 50 (30−90) to 70 (50−100) respectively (p = 0.000). All women showed a statistically significant amelioration of FSDS and ICIQ-SF scores. Anatomical success rate after 24 months was 83.7 %. Conclusionsl-HUSLS appears to be a safe, feasible and effective treatment for advanced pelvic organ prolapse with high rates of patient self-reported cure.

External fixation with bone cement implantation for open calcaneal fractures: A case series

ObjectiveThe purpose of this study was to retrospectively evaluate patients who had open reduction, external fixation and bone cement implantation of open calcaneal fractures. MethodsThe records of 14 patients with open calcaneus fractures from January 2015 to January 2019 were reviewed retrospectively. Clinical evaluations consisting of AOFAS, MFS and EQ-5D VAS scores and radiological evaluations consisting of the height, width and length of the calcaneus as well as Bohler’s and Gissane angle performed at 3 months, 1 year and the last follow-up postoperatively. Time to surgery, wound complications were recorded. ResultsOur study sample consisted of 9 males and 5 females with a mean age of 38.5 ± 9.8 years and a mean follow-up of 31.4 ± 7.7 months. The mean period from injury to surgery was 5.4 ± 1.9 days and the mean duration of hospitalization was 13.2 ± 4.5 days. The AOFAS, MFS and EQ-5D VAS scores were 92.5 ± 10.3, 84.1 ± 9.7 and 86.4 ± 15.1 respectively at the final follow-up. The Bohler’s angle increased from (12.9 ± 3.1)° preoperatively to (28.5 ± 6.3)° at the final follow-up (P < 0.001), with the Gissane’s angle from (104.5 ± 9.7)° to (116.4 ± 8.9)° (P < 0.001). One patients (7.1%) developed pin infections and one patient (7.1%) suffered from dorso-lateral hindfoot hypoaesthesia. There was complete fracture healing without secondary loss of reduction in all cases. ConclusionExternal fixation with bone cement implantation is a valid alternative treatment for the management of displaced open calcaneal fractures with a low rate of complications. Level of evidenceIV, retrospective case series.

Association between in-hospital frailty and health-related quality of life after stroke: the Nor-COAST study

BackgroundStroke survivors are known to have poorer health-related quality of life (HRQoL) than the general population, but less is known about characteristics associated with HRQoL decreasing through time following a stroke. This study aims to examine how in-hospital frailty is related to HRQoL from 3 to 18 months post stroke.MethodSix hundred twenty-five participants hospitalised with stroke were included and followed up at 3 and/or 18 months post stroke. Stroke severity was assessed the day after admission with the National Institutes of Health Stroke Scale (NIHSS). A modified Fried phenotype was used to assess in-hospital frailty; measures of exhaustion, physical activity, and weight loss were based on pre-stroke status, while gait speed and grip strength were measured during hospital stay. HRQoL at 3- and 18-months follow-up were assessed using the five-level version of the EuroQol five-dimensional descriptive system (EQ-5D-5L) and the EuroQol visual analogue scale (EQ-5D VAS). We conducted linear mixed effect regression analyses unadjusted and adjusted for sex, age, and stroke severity to investigate the association between in-hospital frailty and post-stroke HRQoL.ResultsMean (SD) age was 71.7 years (11.6); mean NIHSS score was 2.8 (4.0), and 263 (42.1%) were female. Frailty prevalence was 10.4%, while 58.6% were pre-frail. The robust group had EQ-5D-5L index and EQ-5D VAS scores at 3 and 18 months comparable to the general population. Also at 3 and 18 months, the pre-frail and frail groups had significantly lower EQ-5D-5L indices than the robust group (p < 0.001), and the frail group showed a larger decrease from 3 to 18 months in the EQ-5D-5L index score compared to the robust group (− 0.056; 95% CI − 0.104 to − 0.009; p = 0.021). There were no significant differences in change in EQ-5D VAS scores between the groups.ConclusionThis study on participants mainly diagnosed with mild strokes suggests that robust stroke patients have fairly good and stable post-stroke HRQoL, while post-stroke HRQoL is impaired and continues to deteriorate among patients with in-hospital frailty. This emphasises the importance of a greater focus on frailty in stroke units.Trial registrationClinicalTrials.gov (NCT02650531).

The economic and health impact of rare diseases: A meta-analysis

ObjectiveLack of medical and scientific knowledge on rare diseases (RD) often translates into limited research on them and a subsequent lack of understanding of their economic impact. This meta-analysis aims to fill this gap by evaluating the economic impact of RDs and exploring potential factors associated with the societal burden of RD. MethodsStudies published between January 2010 and February 2017 were identified by searches in the PubMed platform. Thirty eligible studies were identified for inclusion, and nineteen studies were included in the meta-analysis and outcomes were explored. The cost categories include direct healthcare costs, direct non-healthcare formal costs, and direct non-healthcare informal costs. The patients’ health-related quality of life (QoL) dimensions examined include EQ-5D scores, VAS scores and Barthel index, and the carers’ utility outcomes include EQ-5d scores, VAS scores and Zarit scale. Random effects meta-regression models were used for modelling the impact of study and societal characteristics on cost. ResultsAcross all RDs, mean direct healthcare (DH) costs ($16,513) account for the majority of direct costs (mainly driven by drug costs), followed by mean direct healthcare informal (€15,557) and mean direct healthcare formal (€4,579) costs. Body system affected by the RD, Gross Domestic Product (GDP) per capita and public health expenditure in country of study were the most significant determinants in predicting cost. In regards to QoL outcomes, patients with musculoskeletal diseases seem to have the lowest quality of life across EQ-5D scores, VAS scores and Barthel index. The burden on caregivers seemed to be associated with Autoimmune, followed by Musculoskeletal and Respiratory conditions. ConclusionsThis meta-analysis highlights the significant burden of RDs on the health care system and explicitly provides evidence for the magnitude of this impact. Such estimates are necessary to further the debate on priority setting around RDs and their comparison with other chronic diseases. Nevertheless, the large degree of cost variability across RDs might suggest that the use of umbrella terms to raise awareness around RDs’ societal impact might not be warranted.

Outcomes of tissue reconstruction in distal lower leg fractures: a retrospective cohort study

BackgroundOpen and closed fractures can be associated with posttraumatic or postoperative soft tissue defects caused by initial trauma, operative procedures, or infections. This study evaluated the postoperative outcomes in patients with open or closed lower leg fractures, related soft tissue defects, and subsequent flap coverage.MethodsWe performed a retrospective single-center cohort study in a level 1 trauma center. We analyzed the patients treated from January 2012 through December 2017 and recorded demographics, treatment, and outcome data. The outcome data were measured via patient-reported Foot and Ankle Outcomes Scores (FAOS) and EQ-5D-5L scores.ResultsWe included 22 patients with complicated fractures (11 open and 11 closed) and subsequent soft tissue defects and flap coverages. The mean follow-up time was 41.2 months. Twenty-one patients developed infections, and necrosis at the site of surgery manifested in all closed fractures. Therefore, all patients needed soft tissue reconstructions. Preoperatively, 16 patients underwent arterial examinations via angiography and six underwent ultrasound examinations of the venous system. Ten patients had complications involving the flaps due to ischemia and consequent necrosis. The mean EQ-5D index was 0.62 ± 0.27, and EQ-5D VAS score was 57.7 ± 20.2. The mean FAOS was 60.7 ± 22.2; in particular, quality of life was 32.3 ± 28.8. The rate of returning to work in our patient group was 37.5% after 1 year.ConclusionsDistal tibial fractures often require revisions and soft tissue reconstruction. The evaluated patient population had poor outcomes in terms of function, quality of life, and return to work. Furthermore, patients suffering from flap ischemia have worse outcomes than those without flap ischemia.

Localised neuropathic pain in the primary care setting: a cross-sectional study of prevalence, clinical characteristics, treatment patterns, quality of life and sleep performance

Background Localised Neuropathic Pain (LNP) is challenging to diagnose and manage in primary care. Objective To describe clinical characteristics, treatment patterns, quality of life and sleep performance of patients with LNP and estimate its prevalence in primary care. Methods Cross-sectional study in 4 European countries. Patients were identified using a screening tool for LNP. Patients completed the EQ-5D VAS score and Chronic Pain Sleep Inventory (CPSI). Results There were 1030 LNP patients for analysis. They presented a median pain intensity of 6.0 (IQR 4.0–7.0) with a median duration of 30.9 months (IQR 12.0−75.3), despite 97% receiving pain treatment. Main sites affected were the limbs (62% upper/58% lower) and spine (41%). Main aetiologies were neuropathic low back pain (47%), post-surgical neuropathic pain (17%), and diabetic poly-neuropathy (12%). Thirty percent received a single analgesic (2% topical), while combinations comprised 43% systemic-systemic, 24% topical-systemic, 1% topical-topical. Medications included NSAIDs (45%), anticonvulsants (38%), WHO step 2 opioids (35%), and topical analgesics (27%). In the previous 6 months, 40% had switched treatment. The mean (SD) EQ-5D VAS score was 58 (22.3) and the mean (SD) EQ-5D summary score (UK tariff) was 0.62 (0.25). Patients had a CPSI mean index of 41/100, and sleeping pills were used by 33% of patients. The standardized prevalence of LNP by age and sex was 2.01% in the general population and 43.3% among chronic pain patients. Conclusions Many LNP patients reported pain intensities of six on a ten-point scale in average for durations longer than 2.5 years, with quality of life and sleep performance affected, with frequent treatment combinations and switches, suggesting suboptimal pain management.

Clinical outcomes of primary anatomic all-inside Anterior Cruciate Ligament reconstruction using the TransLateral technique: A minimum one-year follow-up study

BackgroundAnatomic all-inside Anterior Cruciate Ligament (ACL) reconstruction using the TransLateral technique is relatively new. This technique utilises single tendon autograft and instruments permitting inside-to-out drilling to create retrograde sockets. Few studies have investigated clinical outcomes following this technique. We investigate clinical outcomes in patients who underwent primary anatomic all-inside ACL reconstruction using the TransLateral technique with a minimum one-year follow-up. MethodsInterrogation of our prospectively maintained database identified patients who underwent surgery from June 2013 to December 2017. Patients were followed up clinically and using patient-reported outcome measures (PROMS) including EQ-5D, KOOS, IKDC and Tegner scores from the National Ligament Registry. Paired two-tailed Student t-test was used to assess for clinical significance. ResultsOne hundred forty-one cases with a mean age of 30 years (range 16.0–60.2) and mean follow-up of 17.4 months (12.1–75.2) were included. Grafts included isolated quadrupled semitendinosus (n = 115) and both quadrupled semitendinosus and gracilis (n = 26). One hundred and two patients (72.3%) had complete peri-operative PROMS. Mean increases in EQ-5D VAS and IKDC scores were 18.9 and 29.2 points (p < 0.001). Significant peri-operative improvements were observed for all KOOS domains (p < 0.001). Median Tegner activity score increased by two levels (p < 0.001). Incidence of graft re-rupture was 5.7% (n = 8), all were following significant knee trauma and seven cases were mid-bundle femoral tunnel placements. ConclusionsAll-inside ACL reconstruction using the TransLateral technique demonstrates good clinical and functional outcomes with low complication and failure rate. Mid-bundle femoral tunnel placements have been abandoned in favour of placement deep within the anteromedial bundle footprint.